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Newly signed bill by Gov. Inslee amends definition of compounding

  |   Legislative, State Regulatory

Substitute House Bill 1445 (SHB 1445) amends the definition of compounding for the practice of pharmacy in RCW 18.64.011(6). The current definition of “compounding” includes simple processes, such as adding water to an antibiotic or for instance, adding saline to a COVID-19 vaccine. Neither the United States Food and Drug Administration (FDA) nor the official United States Pharmacopeia (USP) considers those processes to constitute compounding. SHB 1445 changes the definition to:

(6) “Compounding” means the act of combining two or more ingredients in the preparation of a prescription. Reconstitution and mixing of (a) sterile products according to federal food and drug administration-approved labeling does not constitute compounding if prepared pursuant to a prescription and administered immediately or in accordance with package labeling, and (b) nonsterile products according to federal food and drug administration-approved labeling does not constitute compounding if prepared pursuant to a prescription.

The change will align Washington State’s definition of compounding with that of the FDA and USP in their forthcoming revised chapters, lower administrative burdens for pharmacists, and facilitate patient safety and access to medication.

Governor Inslee signed SHB 1445 on April 16, 2021, and the law will go into effect 90 days after the last day of the session, or July 24, 2021.

 

Posted April 30, 2021